Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

NCT ID: NCT01714960

Last Updated: 2014-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

Brief Summary

• To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2).
• To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.

Conditions

Healthy Volunteers and Glaucoma Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Healthy volunteers low dose

MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.

Group Type: EXPERIMENTAL

MRZ-99030 eye drops 5mg/mL

Intervention Type: DRUG

Healthy volunteers high dose

MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.

Group Type: EXPERIMENTAL

MRZ-99030 eye drops 20mg/mL

Intervention Type: DRUG

Glaucoma patients

MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.

Group Type: EXPERIMENTAL

MRZ-99030 eye drops 20mg/mL

Intervention Type: DRUG

Placebo

Placebo eye drops, 1-3 drops three times per day, duration: 16 days.

Group Type: PLACEBO_COMPARATOR

Placebo to MRZ-99030 eye drops

Intervention Type: DRUG

Interventions

MRZ-99030 eye drops 5mg/mL

Intervention Type: DRUG

MRZ-99030 eye drops 20mg/mL

Intervention Type: DRUG

Placebo to MRZ-99030 eye drops

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

For stage 1:

• Healthy volunteers

For stage 2:

• Glaucoma patients

Exclusion Criteria

For stage 2:

• Any relevant eye disease other than glaucoma

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

Merz Pharmaceuticals GmbH

Locations

Parexel International GmbH, Early Phase Clinical Unit

Berlin, , Germany

Countries

Germany

Other Identifiers

2012-002664-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MRZ99030_1001_1

Identifier Type: -

Identifier Source: org_study_id